Prostate Reirradiation Toxicity Outcomes Feasibility Study

NCT05614700 | Not Yet Recruiting

• 1 other identifier: 21/YH/0305
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The RO-PIP trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage ultra-hypofractionated external beam radiotherapy or high dose rate brachytherapy and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.

Conditions

Prostate Cancer; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Treatment Feasibility

  Recruitment rates for the whole 24-month recruitment period will be reported overall and per recruiting site. The average recruitment rate per month and in total over the formal monitoring period will be reported.

  24 months

Secondary Outcomes (2)

• Patient Reported Toxicity

  0-3 months and >3 months

• Clinician Reported Toxicity

  0-3 months and >3 months

Other Outcomes (4)

• Imaging biomarkers

  1 month and 12 months

• Imaging Reproducibility

  Baseline, 1 and 12 months

• Hypoxia Gene Signature

  Baseline

Study Arms (2)

High dose-rate brachytherapy

ACTIVE COMPARATOR

Two HDR-BT treatment schedules, either a single fraction 19Gy treatment or 27Gy in 2 fractions approximately 2 weeks apart will be used to be decided by treating centre.

Radiation: Brachytherapy

Ultra-hypofractionated external beam radiotherapy

EXPERIMENTAL

Patients will receive 5 fractions of 7.25Gy per fraction which will be delivered alternate days over no more than 2 weeks to provide a total dose of 36.25Gy.

Radiation: Sterotactic Body Radiotherapy

Interventions

Brachytherapy RADIATION

High Dose-Rate Brachytherapy

High dose-rate brachytherapy

Sterotactic Body Radiotherapy RADIATION

Hypofractionated External Beam Radiotherapy

Ultra-hypofractionated external beam radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male individuals aged over 18 years
• Histologically confirmed locally recurrent prostate cancer (following previous radiotherapy no less than 2 years ago)
• No metastatic disease
• Able and willing to provide an informed consent to participate
• World Health Organisation (WHO) performance status 0-2
• Reasonable urinary function (IPSS \< 20 and Qmax \> 10 ml/second on flow tests)
• Greater than 10 year life expectancy

You may not qualify if:

• Patients who are unfit for a general anaesthetic due to other comorbidities
• Clinical or radiological evidence of metastatic prostate disease
• Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
• Contraindication or intolerance of magnetic resonance scanning
• Prior prostatectomy
• History of inflammatory bowel disease.

Sponsors & Collaborators

• University of Leeds: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Ann Henry

  University of Leeds

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Henry

CONTACT

0113 2067630; a.henry@leeds.ac.uk

Jim Zhong

CONTACT

0113 2067630; j.zhong@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Clinical Oncology

Model Details: Randomised Feasibility Study

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 14, 2022
• Study Start: November 15, 2022
• Primary Completion: November 15, 2024
• Study Completion (Estimated): November 15, 2026
• Last Updated: November 15, 2022

Record last verified: 2022-11